Evaluating the Safety of HCAR19 (Now Actalycabtagene Autoleucel- Actaly-CelT), a Novel Humanized CD19-Directed Chimeric Antigen Receptor T-Cells in Pediatric, Adolescents, and Young Adults with Relapsed/ Refractory B- Acute Lymphoblastic Leukemia (ESHA) - Report of Phase-1B

被引：2

作者：

Narula, Gaurav ^{[1
]}

Keerthivasagam, Swaminathan ^{[2
]}

Jain, Hasmukh ^{[1
]}

Dhamne, Chetan ^{[2
]}

Tembhare, Prashant ^{[3
]}

Subramanian, Papagudi Ganesan ^{[3
]}

Patkar, Nikhil ^{[3
]}

Poojary, Minal ^{[4
]}

Nisar, Albeena ^{[5
]}

Pandit, Deepali ^{[6
]}

Pandit, Khushali ^{[7
]}

Karulkar, Atharva ^{[8
]}

Jaiswal, Ankesh Kumar ^{[8
]}

Khan, Aalia ^{[8
]}

Shah, Shreshtha ^{[8
,9
]}

Firfiray, Afrin ^{[8
]}

Pendhari, Juber ^{[8
]}

Asija, Sweety ^{[8
]}

Chowdury, Ambalika ^{[8
]}

Banik, Ankit ^{[8
]}

Moulik, Nirmalya Roy ^{[2
]}

Srinivasan, Shyam ^{[10
]}

Bhosle, Shilpushp ^{[11
]}

Hiregoudar, Sumathi ^{[3
]}

Ojha, Shashank ^{[3
]}

Nayak, Lingaraj ^{[3
,12
]}

Thorat, Jayshree ^{[13
]}

Bagal, Bhausaheb ^{[3
,12
]}

Sengar, Manju ^{[1
]}

Jindal, Nishant ^{[3
,12
]}

Chichra, Akanksha ^{[12
]}

Mirgh, Sumeet ^{[3
,12
]}

Gokarn, Anant ^{[3
,12
]}

Punatar, Sachin ^{[3
,12
]}

Rajadhyaksha, Sunil ^{[14
]}

Khattry, Navin ^{[3
,12
]}

Banavali, Shripad ^{[15
]}

Highfill, Steven ^{[16
]}

Shah, Nirali N. ^{[17
]}

Purwar, Rahul ^{[18
]}

机构：

[1] Homi Bhabha Natl Inst, Dept Med Oncol, Tata Mem Ctr, Mumbai, Maharashtra, India

[2] Homi Bhabha Natl Inst, Dept Pediat Oncol, Tata Mem Ctr, Mumbai, Maharashtra, India

[3] Homi Bhabha Natl Inst, Dept Hematopathol, Tata Mem Ctr, Adv Ctr Treatment Res & Educ Canc ACTREC, Navi Mumbai, India

[4] Homi Bhabha Natl Inst, Dept Transfus Med, Tata Mem Ctr, Navi Mumbai, India

[5] ACTREC, CAR T & Cell Therapy Ctr, Tata Mem Ctr, Sci Off D, Mumbai, Maharashtra, India

[6] Tata Mem Hosp, CAR T & Cell Therapy Ctr, ACTREC, Kharghar, India

[7] Tata Mem Hosp, CAR T & Cell Therapy Ctr, ACTREC, Mumbai, Maharashtra, India

[8] Indian Inst Technol, Dept Biosci & Bioengn, Mumbai, Maharashtra, India

[9] ImmunoACT, Immunoadopt Cell Therapy Private Ltd, Mumbai, Maharashtra, India

[10] Homi Bhabha Natl Inst, Dept Pediat Oncol, Tata Mem Ctr, Mumbai, Maharashtra, India

[11] Homi Bhabha Natl Inst, Dept Crit Care & Anaesthesiol, Tata Mem Ctr, Mumbai, Maharashtra, India

[12] Homi Bhabha Natl Inst, Dept Med Oncol, BMT Unit,Tata Mem Ctr, Adv Ctr Treatment Res & Educ Canc ACTREC, Navi Mumbai, India

[13] Homi Bhabha Natl Inst, Dept Med Oncol, Tata Mem Ctr, Mumbai, Maharashtra, India

[14] Homi Bhabha Natl Inst, Dept Transfus Med, Tata Mem Ctr, Mumbai, Maharashtra, India

[15] Tata Mem Hosp, Dept Med Oncol, Homi Bhabha Natl Inst, Mumbai, Maharashtra, India

[16] Natl Inst Hlth, Ctr Cellular Engn, Bethesda, MD USA

[17] Natl Inst Hlth, Pediat Oncol Branch, Bethesda, MD USA

[18] Indian Inst Technol B, Dept Biosci & Bioengn, Mumbai, Maharashtra, India

来源：

BLOOD | 2023年 / 142卷

关键词：

D O I：

10.1182/blood-2023-180867

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

引用

页数：6

共 28 条

[1] EXPLORING THE ROLE OF INDIGENOUSLY DEVELOPED NOVEL HUMANIZED CD19-DIRECTED CHIMERIC ANTIGEN RECEPTOR(HCAR19) T-CELLS FOR RELAPSED/REFRACTORY B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA- A PILOT OPEN-LABEL SINGLE-ARM PHASE-I STUDY
Narula, Gaurav
Purwar, Rahul
Jain, Hasmukh
Dhamne, Chetan
Tembhare, Prashant
Pg, Subramanian
Patkar, Nikhil
Poojary, Minal
Nisar, Albeena
Pandit, Deepali
Karulkar, Atharva
Rafiq, Afrin
Khan, Aalia
Jaiswal, Ankesh
Suvasia, Prashant
Asija, Sweety
Suvasia, Priyanshi
Pendhari, Juber
Shah, Shreshtha
Moulik, Nirmalya Roy
Swaminathan, K.
Bhosle, Shilpushp
Hiregoudar, Sumathi
Ojha, Shashank
Nayak, Lingaraj
Thorat, Jayashree
Bagal, Bhausaheb
Sengar, Manju
Jindal, Nishant
Chichra, Akanksha
Mirgh, Sumeet
Gokarn, Anant
Punatar, Sachin
Rajadhyaksha, Sunil
Khattry, Navin
Banavali, Sripad
PEDIATRIC BLOOD & CANCER, 2022, 69 : S328 - S329
[2] Long-term safety and activity of humanized CD19 chimeric antigen receptor T cells for children and young adults with relapsed/refractory acute lymphoblastic leukemia
王诗媛
China Medical Abstracts(Internal Medicine), 2022, 39 (04) : 231 - 232
[3] Efficacy of Humanized CD19-Targeted Chimeric Antigen Receptor (CAR)-Modified T Cells in Children and Young Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia
Maude, Shannon L.
Barrett, David M.
Rheingold, Susan R.
Aplenc, Richard
Teachey, David T.
Callahan, Colleen
Baniewicz, Diane
White, Claire
Talekar, Mala K.
Shaw, Pamela A.
Brogdon, Jennifer L.
Young, Regina M.
Scholler, John
Marcucci, Katherine T.
Levine, Bruce L.
Frey, Noelle
Porter, David L.
Lacey, Simon F.
Melenhorst, J. Joseph
June, Carl H.
Grupp, Stephan A.
BLOOD, 2016, 128 (22)
[4] Humanized CD19-specific chimeric antigen-receptor T-cells in 2 adults with newly diagnosed B-cell acute lymphoblastic leukemia
Jiang Cao
Hai Cheng
Ming Shi
Gang Wang
Wei Chen
Kunming Qi
Huizhong Li
Jianlin Qiao
Jing Zhao
Qingyun Wu
Lingyu Zeng
Guangjun Jing
Junnian Zheng
Kailin Xu
Leukemia, 2019, 33 : 2751 - 2753
[5] Humanized CD19-specific chimeric antigen-receptor T-cells in 2 adults with newly diagnosed B-cell acute lymphoblastic leukemia
Cao, Jiang
Cheng, Hai
Shi, Ming
Wang, Gang
Chen, Wei
Qi, Kunming
Li, Huizhong
Qiao, Jianlin
Zhao, Jing
Wu, Qingyun
Zeng, Lingyu
Jing, Guangjun
Zheng, Junnian
Xu, Kailin
LEUKEMIA, 2019, 33 (11) : 2751 - 2753
[6] Immunophenotypic changes in leukemic blasts in children with relapsed/refractory B-cell precursor acute lymphoblastic leukemia after treatment with CD19-directed chimeric antigen receptor (CAR)-expressing T cells
Mikhailova, Ekaterina
Illarionova, Olga
Shelikhova, Larisa
Zerkalenkova, Elena
Molostova, Olga
Olshanskaya, Yulia
Novichkova, Galina
Maschan, Alexey
Maschan, Michael
Popov, Alexander
HAEMATOLOGICA, 2022, 107 (04) : 970 - 974
[7] A Feasibility and Safety Study of a Novel CD19-Directed Synthetic T-Cell Receptor and Antigen Receptor (STAR) T-Cell Therapy for Refractory and Relapsed (R/R) B Cell Acute Lymphoblastic Leukemia (B-ALL)
Zhang, Xian
Wang, Jiasheng
Liu, Yue
Yang, Junfang
Li, Jingjing
Zhang, Gailing
Shi, Yanze
He, Jiujiang
Song, Dan
Li, Wenqian
Xia, Shulian
Zhang, Min
Zhou, Zhixiao
Jia, Lemei
Zheng, Hongli
Lin, Xin
Lu, Peihua
BLOOD, 2020, 136
[8] Outcomes after Reinfusion of CD19-Specific Chimeric Antigen Receptor (CAR)-Modified T Cells in Children and Young Adults with Relapsed/Refractory B-Cell Acute Lymphoblastic Leukemia
Myers, Regina M.
Devine, Kaitlin
Li, Yimei
Lawrence, Sophie
Leahy, Allison Barz
Liu, Hongyan
Vernau, Lauren
Callahan, Colleen
Baniewicz, Diane
Kadauke, Stephan
McGuire, Regina
Cameron, Margaret A.
DiNofia, Amanda M.
Rheingold, Susan R.
Aplenc, Richard
June, Carl H.
Grupp, Stephan A.
Wray, Lisa
Maude, Shannon L.
BLOOD, 2021, 138
[9] Humanized CD19-Targeted Chimeric Antigen Receptor (CAR) T Cells in CAR-Naive and CAR-Exposed Children and Young Adults With Relapsed or Refractory Acute Lymphoblastic Leukemia
Myers, Regina M.
Li, Yimei
Leahy, Allison Barz
Barrett, David M.
Teachey, David T.
Callahan, Colleen
Fasano, Christina C.
Rheingold, Susan R.
DiNofia, Amanda
Wray, Lisa
Aplenc, Richard
Baniewicz, Diane
Liu, Hongyan
Shaw, Pamela A.
Pequignot, Edward
Getz, Kelly D.
Brogdon, Jennifer L.
Fesnak, Andrew D.
Siegel, Donald L.
Davis, Megan M.
Bartoszek, Chelsie
Lacey, Simon F.
Hexner, Elizabeth O.
Chew, Anne
Wertheim, Gerald B.
Levine, Bruce L.
June, Carl H.
Grupp, Stephan A.
Maude, Shannon L.
JOURNAL OF CLINICAL ONCOLOGY, 2021, 39 (27) : 3044 - +
[10] MANAGING RELAPSED/REFRACTORY ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) PATIENTS ON A PHASE I TRIAL RECEIVING AUTOLOGOUS CAR (CHIMERIC ANTIGEN RECEPTOR) T-CELLS GENETICALLY MODIFIED TO TARGET B CELL SPECIFIC ANTIGEN CD19
Quintanilla, Hilda S.
Miale-Mayer, Donna
Llerandi, Diane
ONCOLOGY NURSING FORUM, 2014, 41 (02) : E102 - E103

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